ViiV Healthcare and Desano Pharmaceuticals' Manufacturing Agreement Will Allow Competitive Supply

Agreement reinforces ViiV Healthcare commitment to improving access to HIV treatments

LONDON, July 2, 2015 /CNW/ - ViiV Healthcare and Desano Pharmaceuticals (Desano) today announced a strategic manufacturing agreement to enable production in China of dolutegravir. The agreement will offer an additional source of the dolutegravir active pharmaceutical ingredient (API), and will allow ViiV Healthcare to offer a competitive supply of the finished product (dolutegravir 50mg, marketed under the name Tivicay®) for China and a number of developing countries, subject to national approvals. This strengthens ViiV Healthcare's commitment to improve access to its treatments for people living with HIV, especially in countries hardest hit by the disease.

"This manufacturing agreement with Desano for dolutegravir is a significant achievement to facilitate access to our medicines. With our recent agreement with the Medicines Patent Pool and our other access initiatives this deal is aligned with our ongoing commitment to improve access to our medicines in countries where the need is greatest." said Dr Dominique Limet, Chief Executive Officer, ViiV Healthcare.

Based in Shanghai, Desano is a high quality manufacturer, therefore well suited to partner with ViiV Healthcare. Under the agreement, Desano will manufacture the API of dolutegravir to feed in to the GSK/ViiV Healthcare supply chain for onward sale in China and developing countries covered by the agreement. ViiV Healthcare and Desano are also exploring further options for future manufacture of finished drug product and fixed dose combinations of dolutegravir with APIs.

"As one of the leading Chinese pharmaceutical companies dedicated to developing, manufacturing and supplying antiretroviral (ARV) APIs for HIV and finished pharmaceutical products, Desano is honored to cooperate with ViiV Healthcare to manufacture a high quality, competitive supply of dolutegravir and its combinations," said Ying Kan, President of Desano Pharmaceuticals. "We believe that working together with ViiV Healthcare we can better contribute to the global goal of making treatment options available to patients across the globe."

Dolutegravir is an integrase strand transfer inhibitor (INSTI) for use in combination with other antiretroviral agents for the treatment of HIV. Integrase inhibitors block HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection.

Tivicay is approved in over 70 countries across North America, Europe, Asia, Australia, Africa and Latin America. A regulatory application for dolutegravir is currently being evaluated by the China Food and Drug Administration (CFDA).

UNAIDS estimates that approximately 780,000 (620,000 to 940,000) people are infected with HIV/AIDS in China. With more than 40,000 new HIV infections and over 25,000 deaths reported in 2011.^[¹^] People living with HIV/ AIDS in China who meet the national treatment criteria are referred to receive care through the China National Free Antiretroviral Treatment Programme (CNFATP).^[²^] Still, only an estimated 126,000 people with HIV were receiving antiretroviral treatment, with an estimated 76% of adults and children who met the criteria receiving antiretroviral treatment.^[¹^]

ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV. Shionogi joined in October 2012. The company's aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and new HIV medicines, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit http://www.viivhealthcare.com

Founded in 1996, Desano Pharmaceutical is a leading vertically integrated pharmaceuticals company specialising in developing and manufacturing of generic ARV APIs and formulations with 4 manufacturing sites located in China approved by the agencies of CFDA, USFDA and WHO. Desano Pharmaceutical is one of the key ARV APIs suppliers for low to middle income countries, supporting over 4 million AIDS patients treatment. For more information, please visit http://www.desano.com

FDA Indication and Usage: TIVICAY is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

Use of TIVICAY in INSTI-experienced patients should be guided by the number and type of baseline INSTI substitutions. The efficacy of TIVICAY 50 mg twice daily is reduced in patients with an INSTI-resistance Q148 substitution plus 2 or more additional INSTI-resistance substitutions including T66A, L74I/M, E138A/K/T, G140S/A/C, Y143R/C/H, E157Q, G163S/E/K/Q, or G193E/R.

Contraindication: TIVICAY is contraindicated (1) in patients with previous hypersensitivity reaction to dolutegravir, and (2) in patients receiving dofetilide (antiarrhythmic) due to the potential for increased dofetilide plasma concentrations and the risk for serious and/or life-threatening events.

Hypersensitivity Reactions: Hypersensitivity reactions have been reported and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury. The events were reported in 1% or fewer subjects receiving TIVICAY in Phase 3 clinical trials. Discontinue TIVICAY and other suspect agents immediately if signs or symptoms of hypersensitivity reaction develop (including but not limited to severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters or peeling of the skin, oral blisters or lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema, difficulty breathing). Monitor clinical status, including liver aminotransferases, and initiate appropriate therapy. Delay in stopping treatment with TIVICAY or other suspect agents after the onset of hypersensitivity may result in a life-threatening reaction. TIVICAY is contraindicated in patients who have experienced a hypersensitivity reaction to dolutegravir.

Effects on Serum Liver Biochemistries in Patients with Hepatitis B or C Coinfection: Patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations with use of TIVICAY. In some cases the elevations in transaminases were consistent with immune reconstitution syndrome or hepatitis B reactivation particularly in the setting where anti-hepatitis therapy was withdrawn. Appropriate laboratory testing prior to initiating therapy and monitoring for hepatotoxicity during therapy with TIVICAY are recommended in patients with underlying hepatic disease such as hepatitis B or C.

Fat Redistribution: Redistribution/accumulation of body fat has been observed in patients receiving antiretroviral therapy.

Immune Reconstitution Syndrome: During the initial phase of treatment, immune reconstitution syndrome can occur, which may necessitate further evaluation and treatment. Autoimmune disorders have been reported to occur in the setting of immune reconstitution; the time to onset is more variable and can occur many months after initiation of treatment.

Adverse Reactions: The most commonly reported (≥2%) adverse reactions of moderate to severe intensity in treatment naïve adult subjects in any one trial receiving TIVICAY in a combination regimen were insomnia (3%), fatigue (2%), and headache (2%).

Drug Interactions: Co-administration of TIVICAY with drugs that are strong inducers of UGT1A1 and/or CYP3A4 may result in reduced plasma concentrations of dolutegravir and require dose adjustments of TIVICAY.

- TIVICAY should be taken 2 hours before or 6 hours after taking cation-containing antacids or laxatives, sucralfate, oral iron supplements, oral calcium supplements, or buffered medications.

- Consult the full Prescribing Information for TIVICAY for more information on potentially significant drug interactions, including clinical comments.

Pregnancy: Pregnancy category B. TIVICAY should be used during pregnancy only if the potential benefit justifies the potential risk. An Antiretroviral Pregnancy Registry has been established.

Breastfeeding: Breastfeeding is NOT recommended due to the potential for HIV transmission and the potential for adverse reactions in nursing infants.

Paediatric Patients: Safety and efficacy of TIVICAY has not been established in children younger than 12 years old, or weighing <40 kg, or in INSTI-experienced paediatric patients with documented or clinically suspected INSTI resistance.

ViiV Healthcare and Desano Pharmaceuticals' Manufacturing Agreement Will Allow Competitive Supply of Dolutegravir in China and Several Developing Countries

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